In quality control in an automatic analyzer at clinical examination, a quality control substance (control sample) is measured at predetermined time intervals during the measurements of patient specimens or measured whenever a predetermined number of specimens have been measured. A check is performed to determine whether the result of such quality control substance measurement is within a control range defined for the quality control substance. Alternatively, diurnal variation and day-to-day variation are studied to determine whether the degree of precision is within a control range. Further, the result of quality control substance measurement and the result of calibration performed at predetermined time intervals are used to determine whether the automatic analyzer is normal, whether a reagent is deteriorated or otherwise abnormal, and whether a standard solution is properly prepared.
The above-described quality control is exercised by having a clinical laboratory technician totalize, record, and store the results of calibration and quality control substance measurement.
A control value for a quality control substance is not only managed by a clinical laboratory technician in a clinical laboratory, but also managed by a public institution.
(1) The clinical laboratory manages the result of quality control substance measurement by using a commercially available quality control substance.
(2) The clinical laboratory sends data derived from its quality control substance measurement to a reagent manufacturer through a network or by mail or the like. The reagent manufacturer then performs statistical processing on the data and returns the result of processing to each hospital. The clinical laboratory manages the results of measurement and statistical processing.(3) Japanese Society of Laboratory Medicine, Japan Medical Association, or other similar organization simultaneously distributes a common sample to hospitals, clinical laboratory centers, and other similar institutions in Japan several times a year and has them measure the common sample. The institutions totalize and perform statistical processing on the results of measurements. In addition, relevant surveys are conducted, for instance, on an individual prefecture basis or on an individual hospital group basis.(4) An automatic analyzer manufacturer, which has sold and installed its automatic analyzer to various clinical laboratories in hospitals and to various laboratory centers, has established a practical remote monitoring system by connecting its service server to the automatic analyzer through a network.
A technology related to (4) above is described in Patent Document 1. A clinical laboratory in each hospital transmits, for example, a calibration result, a quality control substance measurement result, a reagent lot number and reagent bottle number used during measurement, a calibrator lot number/vial number, a quality control substance lot number/vial number, and alarm information in real time to a support center through a network. The support center totalizes and performs statistical processing on the calibration result and quality control substance data, and performs checks, for instance, to determine daily changes and the deviation from a reference value. The clinical laboratory accesses the support center through the network to confirm the quality control in an automatic analyzer.